NE Dallas News

There were eight companies in cities associated with Collin County that received FDA citations as a result of eight inspections conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 46.7% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• Donor testing of HCT/P donors considered eligible was not negative or nonreactive for relevant communicable disease agents.
• Documentation of the donor-eligibility determination and the date of the donor-eligibility determination was not maintained.
• Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the .

Of the companies cited, seven should take voluntary actions to correct their managing operations (87.5%). Additionally, one company had to take regulatory and/or administrative actions (12.5%).

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Company Name	Area of Business	Inspection Date	Issue Cited
Buda Juice, LLC	Food and Cosmetics	11/14/2023	HACCP plan - monitoring procedures - none listed
Buda Juice, LLC	Food and Cosmetics	11/14/2023	HACCP plan - corrective action plan not included
Cookies-n-Milk, LLC	Food and Cosmetics	10/19/2023	Hazard analysis - Identification of hazard
Cookies-n-Milk, LLC	Food and Cosmetics	10/19/2023	Supply-chain program - Implement
Divine Design Manufacturing	Food and Cosmetics	11/21/2023	Specifications - component identity
Divine Design Manufacturing	Food and Cosmetics	11/21/2023	Specifications - identity, purity, strength, composition
Divine Design Manufacturing	Food and Cosmetics	11/21/2023	Component - verify identity, dietary ingredient
Divine Design Manufacturing	Food and Cosmetics	11/21/2023	Documentation - qualify supplier
Eminent Spine, LLC	Devices	10/13/2023	Info evaluated to determine if event was reportable
Eminent Spine, LLC	Devices	10/13/2023	Design Validation - Risk analysis not performed/inadequate
Eminent Spine, LLC	Devices	10/13/2023	Approval, inadequate purchasing data
Fertility and Advanced Reproductive Medicine at UTSW	Biologics	12/13/2023	Donor testing not negative for CD agents
Fertility and Advanced Reproductive Medicine at UTSW	Biologics	12/13/2023	Documentation--determination, by whom, date
Fertility and Advanced Reproductive Medicine at UTSW	Biologics	12/13/2023	Risk factors, clinical evidence
Fertility and Advanced Reproductive Medicine at UTSW	Biologics	12/13/2023	Eligibility not required--warning labels
La Fabrica, LLC	Food and Cosmetics	11/06/2023	Manufacturing, processing, packing, holding - Controls
Parvez Mantry	Drugs	11/14/2023	FD-1572, protocol compliance
Post Oak Innovations, Inc.	Devices	10/13/2023	Document change records, maintained.
Post Oak Innovations, Inc.	Devices	10/13/2023	Acceptable supplier records, inadequate records
Post Oak Innovations, Inc.	Devices	10/13/2023	Lack of or inadequate procedures